BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 8684111 · Received June 10, 2019

    Report

    Report Number
    3003464075-2019-00028
    Event Type
    Death
    Date Received
    June 10, 2019
    Date of Event
    May 20, 2019
    Report Date
    June 10, 2019
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED CYCLER WAS NOT RECEIVED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED WHICH CONFIRMED THAT THE PRODUCT MET ALL QUALITY CRITERIA AND MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THERE IS NO INFORMATION TO INDICATE THAT A MALFUNCTION OCCURRED. UDI #: (B)(4). THIS REPORT AND THE INFORMATION CONTAINED HEREIN IS SUBMITTED TO THE APPLICABLE COMPETENT AUTHORITY UNDER MEDICAL DEVICE DIRECTIVE 93/42/EEC AND REPRESENTS THE INFORMATION AVAILABLE TO THE COMPANY AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ON (B)(6) 2019 FROM THE HOME THERAPY NURSE (HTN) REGARDING A (B)(6) MALE PATIENT WITH A COMPLEX UNSPECIFIED MEDICAL HISTORY INCLUDING HYPOTENSION AND NON-COMPLIANCE WITH HEMODIALYSIS TREATMENTS, WHO ELECTED TO PERFORM A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2019 WITHOUT HIS CAREGIVER PRESENT AND EXPIRED AT AN UNKNOWN TIME. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019 FROM THE HTN REVEALED THE PATIENT WAS FOUND EXPIRED AT APPROXIMATELY 1AM ON (B)(6) 2019 WITH A VISIBLE LACERATION ON HIS HEAD. THE TIME AND CAUSE OF DEATH WERE NOT PROVIDED, AND IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE DEVICE AT THE TIME OF THE DEATH. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476635 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. NX1000-1

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death